Retrospective Analysis of Treatment Outcomes in Patients With Bacterial Overgrowth Syndrome Diagnosed by D-Xylose Breath Testing

Completed

• Conditions: Small Intestinal Bacterial Overgrowth Syndrome (SIBO); Small Bowel Bacterial Overgrowth Syndrome (SBBOS)

• Registration Number: NCT01324895
• Lead Sponsor: University of Florida

Brief Summary

The objective of this study is to compare the efficacy of prokinetics versus antibiotics versus a combination of antibiotics plus prokinetics in the eradication of Small-Intestinal Bacterial Over-Growth Syndrome (SIBO) in those with and without a positive D-xylose Breath Test.

Hypothesis: Patients with SIBO treated with a combination of prokinetics and in particular octreotide and antibiotics will have reduced recurrence rates of SIBO than either therapy given alone.

Detailed Description

We want to determine whether treatment with prokinetics such as Octreotide, Azithromycin, Erythromycin or Tegaserod alone, versus antibiotics alone, or combination of antibiotics plus prokinetics results in symptomatic improvement in patients with SIBO (defined by a positive D xylose Breath test).

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2011-03-24
• Study First Submitted QC: 2011-03-28
• Study First Posted: 2011-03-29
• Status Verified: 2012-03
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Last Update Submitted: 2012-03-23
• Last Update Posted: 2012-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 944

Inclusion Criteria

• Patients who have had 14 C-D-Xylose Breath test performed in GI Motility Laboratory at the University of Florida

Exclusion Criteria

• Those who cannot tolerate 14 C-D-Xylose Breath test for any reason

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
clinical response to treatments as measured by changes in patients' GI symptoms, weight and lab data	A retrospective chart review of up to 8 clinical visits between January 2000 and September 2010 will be conducted on all patients who have had a D-Xylose Breath Test at the Shands Motility Laboratory at the University of Florida during this time period	Overall clinical response to each treatment (antibiotic, pro-kinetic, or both) and any symptoms reported in up to 8 separate clinical visits in the follow-up of these patients during the above mentioned time period will be analyzed and reviewed retrospectively using the patients' charts.

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States